Effect of Colostrum on Gut Permeability and Endotoxin Level in Chronic Alcoholic Disease

Gangnam Severance Hospital34 enrolled

Overview

Chronic alcohol ingestion is related with leaky gut syndrome. Colostrum is well-studied that it has a effect of decreasing the degree of leaky gut syndrome. So the investigators are planning to find out whether Colostrum has a effect of decreasing the degree of leaky gut syndrome.

We randomly sort the participant as placebo group and colostrum group. Each group consists of 17 people. and the duration of our study for one participant is 3 weeks. (Participant takes colostrum for 3 weeks.) When a person gets leaky gut syndrome, his or her endotoxin and lactulose/mannitol ratio (L/M ratio, in urine) can elevate. So We will compare the value of those two parameters and LFT. etc. after the administration of colostrum or placebo.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Leaky Gut Syndrome

Interventions

colostrumDIETARY_SUPPLEMENT

colostrum, 2g, 2 times a day, for 3 weeks

Eligibility

Sex: MALEMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Men aged over 20 who's alcohol consumption per day is 20.0gram average * He must agree to participate this trial voluntarily. * Liver function test within 3 months : AST more than 30 or ALT more than 33 or Gamma-GT more than 46 * Men who have result of Ultra-sono result of abdomen without Liver cirrhosis Exclusion Criteria: * Hepatitis B or C , liver cirrhosis patient * Men who have undergo bowel operation * Men who are taking NSAIDs * Periodontitis or GERD or other G-I tract infection within 2 weeks before enrollment * Men who have been given anticancer drug within one year * Men who have been given antibiotics within 2 weeks * Creatinine level \>= 1.4mg/dl * Men who are taking G-I motility drugs or anti-ulcer drug * Milk allergy

Locations (1)

Gangnam Severance Hospital : Family medicine department

Seoul, South Korea

RECRUITING

Outcomes

Primary Outcomes

endotoxin

Time frame: 1st visit and 3 weeks after 1st visit

Secondary Outcomes

lactulose/mannitol ratio

Time frame: 3 weeks

Central Contacts

Jae Yong Shim, Master

CONTACT

82-02-2019-3155 hongbai96@yuhs.ac.kr

Hong Bae Kim, Bachelor

CONTACT

82-02-584-2823

Data from ClinicalTrials.gov

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